SEP-363856 is showing initial efficacy and long-term safety in adult patients.
The 2020 American Psychiatric Association (APA) Annual Meeting was cancelled this year, with plans made to convert the world-leading psychiatry conference into a two-part virtual session and educational platform for attendees.In lieu of regular on-site coverage, HCPLive® will be running a series of interviews, insights, and reporting on topics that frequently headline the APA meeting—featuring familiar experts.
New results from a randomized, controlled trial assessing the efficacy and safety of investigative therapy SEP-363856 show the novel-targeting drug reduced symptoms in patients with schizophrenia versus placebo over 4 weeks.
The findings, authored by Kenneth Koblan, PhD, Chief Scientific Officer of Sunovion, and colleagues, show the oral compound might provide significant benefit for adults with schizophrenia—all from a mechanism that deviates from common antipsychotic therapies.
The non-dopamine D2-receptor-binding therapy has shown agonist activity at trace amine-associated receptor 1 (TAAR1) and 5-hydroxytrypatimine type 1A (5-HT1A) receptor—and in this most recent four-week assessment, was associated with a 7.5-point improved reduction in Positive and Negative Symptom Scale (PANSS) improvement from baseline versus placebo at 4 weeks (95% CI, -11.9 to -3.0; P = .0001).
Similar, unadjusted improvements were observed versus placebo on the Clinical Global Impressions Severity (CGI-S) scale and the Brief Negative Symptom Scale (BNSS), and safety outcomes for patients treated with SEP-363856 were largely common—frequent adverse events included somnolence and gastrointestinal symptoms, and investigators reported one sudden cardiac-related death in the treatment group.
Patients treated with the novel compound and placebo reported similar extrapyramidal symptoms and changes in lipid levels, glycated hemoglobin, and prolactin.
What do these findings mean for the state of schizophrenia care, and what is next in clinical research? In an interview with HCPLive®, Koblan discussed his team’s report, the supplemental outcomes of SEP-363856 analysis, and what plans are for longer-outcome trials.